Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT03991533
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis
Sponsor:
AZ Sint-Jan AV
Organization:
Study Overview
Official Title:
Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Detailed Description:
Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.
Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').
Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.
Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').
Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: